CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
HSVTI Formulation 1 +2 morebiological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Healthy adult aged 18 to 40 years
  • ✓Japanese ethnic origin (born in Japan with 4 ethnic Japanese grandparents, able to speak Japanese)
  • ✓HSV-2 seronegative by Western blot at screening
  • ✓Ability to comply with protocol requirements including diary cards and follow-up visits
Key exclusion· 9
  • ✕Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality
  • ✕Immunosuppressive or immunodeficient condition, or confirmed/suspected HIV infection
  • ✕History of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications (meningitis, encephalitis, radiculopathy, myelitis)
  • ✕Recurrent history of or uncontrolled neurological disorders or seizures

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05989672
NCT05989672Phase 1Completed
CompareCT.gov

A Phase 1, Observer-blind, Randomized, Placebo-Controlled Study to Evaluate Reactogenicity, Safety and Immune Response of an HSV-targeted Immunotherapy in HSV-2 Seronegative Japanese Participants Aged 18-40 Years

GlaxoSmithKline·interventional·Posted Aug 14, 2023·Updated Jun 12, 2025

In Brief

A Phase 1 clinical trial evaluating HSVTI Formulation 1, HSVTI Formulation 2, and 1 other intervention for Herpes Simplex. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Simplex
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedAug 14, 2023
Enrollment StartAug 8, 2023
Primary CompletionNov 29, 2023
Study CompletionApr 24, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.9 years ago

Interventions

HSVTI Formulation 1biological

This investigational intervention was administered intramuscularly to HSVTI\_F1 Group.

HSVTI Formulation 2biological

This investigational intervention was administered intramuscularly to HSVTI\_F2 Group.

Placebobiological

This intervention was administered intramuscularly to Placebo group.